DIA Biosimilars 2013

Ethics/Regulatory

Terrifying Budget Numbers

Friday, September 22, 2006 03:52 PM

For all that consumers expect from the U.S. Food and Drug Administration, it is completely irresponsible of the federal government to fund it with less than $2 billion a year. By comparison, that’s exactly the same dollars the federal government is spending each week on the war in Iraq.

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Cenduit: Now with Patient Reminders

FDA Offers Guidance on Informed Consent Exemptions

Wednesday, September 13, 2006 04:50 PM

Helping to quell a storm of a controversy, the FDA has issued new guidelines describing the circumstances when informed consent can be waived for clinical trials in emergency or ambulatory settings. It's a big issue. Informed consent is a 'sacred cow' in today's clinical trial industry, and rightly so.

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CRF Health – eCOA Forum

Disapproving Look

Tuesday, September 5, 2006 09:54 AM

Well, it’s about time the FDA took a hard look at the compounding of drugs at some pharmacies. Until now, the FDA sort of looked the other way at pharmacists who custom-blended drugs from bulk ingredients. Particularly popular have been custom hormone replacement therapies or drugs that remove an ingredient that may be an allergen.

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The Right To Use Unproven Treatments?

Tuesday, August 8, 2006 03:11 PM

It’s ironic that at a time when several high-profile marketed drugs have been given a black box warning or withdrawn from the market that the Abigail Alliance has gathered steam.

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Adapting To A New Kind Of Trial

Monday, July 17, 2006 11:29 AM

It’s great to see the FDA making a move this week to develop guidelines for adaptive clinical trials. Their time has come, given recent advances in scientific tools, such as toxicogenomic assays.

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September 30

Novartis-Walgreens pilot study blurring the line between retail pharmacy, investigative site

CISCRP to launch traveling science museum exhibit to demystify clinical trial participation

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The CenterWatch Monthly

October

New growth and decline in Asia clinical trials
South Korea, Japan, China see big growth in 1572s, while India posts huge drop

Harnessing Big Data to transform clinical trials
From protocol to patient recruiting, data analytics can yield valuable insights

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The CenterWatch Monthly

September

Sponsors look to collaborate on comparator drugs
Co-therapies, comparators are in 60% of studies, cost $25m per company a year

Early adopters implement risk-based monitoring pilot programs
Experiments aim to offer long-term solutions, despite short-term uncertainties

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